Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women

NCT04153513 | Completed Phase 2

• 1 other identifier: Study 2
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled study will be conducted at the accredited Baby Friendly Hospital in Mostar, Bosnia and Herzegovina. The study will include primiparas who have established breast feeding at the maternity ward and developed symptoms of painful and sore nipples within 72 hours from childbirth. Participants will be allocated in two groups and will receive education prior to the study.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (2)

• Change in nipple pain severity

  An abbreviated version of the McGill Questionnaire (SF-MPQ) will be used to assess the intensity of nipple pain. For the assessment of the current intensity of pain in the nipples will be used subcategories SF-MPQ, the current assessment of pain (PPI). It consists of a verbal scoring scale with values from 0 to 5, 0= No pain, 1= Mild, 2 = Discomforting, 3= Distressing, 4= Horrible, 5= Excruciating

  baseline, 3 and 7 days post randomization

• Nipple damage change

  The baseline assessment of nipple damage will be performed by a validated Nipple Trauma Score (NST). The assessment is performed on scales from 0 to 5 where 0 = no macroscopically visible changes in the skin, 1 = erythema or edema or a combination of both, 2 = superficial damage or no scab on \<25% of the nipple surface, 3 = superficial damage with or without scab on\> 25% of nipple surface, 4 = partial thickness wound with or without scab on \<25% of nipple surface, 5 = partial thickness with or without scab on\> 25% of nipple surface. Three and 7 days after applying the treatment, the condition of the nipple will be evaluated with a Questionnaire on Pain and Damage to the Nipple, where a telephone survey will be performed by the Principal Investigator in order to describe and compare the condition of the nipples.

  baseline, 3 and 7 days post randomization

Secondary Outcomes (3)

• Assessment of breastfeeding self-efficacy

  baseline, 3 and 7 days post randomization

• Breastfeeding duration and exclusivity.

  3 and 7 days post randomization, 3 and 6 months postpartum

• Satisfaction with proposed treatment

  3 and 6 months postpartum

Study Arms (2)

Lanolin

EXPERIMENTAL

Drug: Lanolin

Mother's milk

ACTIVE COMPARATOR

Other: Mother's milk

Interventions

Lanolin DRUG

Lanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

Lanolin

Mother's milk OTHER

After each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

Mother's milk

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparas who have given birth to infants born at full term at between 37-41 weeks gestation
• Mothers complaint of nipple pain with any sign of nipple trauma to one or both nipples,
• Access to telephone
• Signed Informed consent

You may not qualify if:

• Primiparas with mental disorders
• Mothers allergy to lanolin
• Mothers with abnormal nipples
• Breast hypoplasia
• Infant with cleft palate
• Ankyloglossia
• Unsigned Informed consent

Sponsors & Collaborators

• University of Mostar: lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

Department of Gynecology and Obstetrics, University Clinical Hospital Mostar

Mostar, HNŽ, 88000, Bosnia and Herzegovina

Location

Related Publications (3)

• Pavicic Bosnjak A, Rumboldt M, Stanojevic M, Dennis CL. Psychometric assessment of the croatian version of the breastfeeding self-efficacy scale-short form. J Hum Lact. 2012 Nov;28(4):565-9. doi: 10.1177/0890334412456240. Epub 2012 Sep 6.

  PMID: 22956741 RESULT

• Abou-Dakn M, Fluhr JW, Gensch M, Wockel A. Positive effect of HPA lanolin versus expressed breastmilk on painful and damaged nipples during lactation. Skin Pharmacol Physiol. 2011;24(1):27-35. doi: 10.1159/000318228. Epub 2010 Aug 18.

  PMID: 20720454 RESULT

• Peric O, Pavicic Bosnjak A, Mabic M, Tomic V. Comparison of Lanolin and Human Milk Treatment of Painful and Damaged Nipples: A Randomized Control Trial. J Hum Lact. 2023 May;39(2):236-244. doi: 10.1177/08903344221135793. Epub 2022 Nov 18.

  PMID: 36401521 DERIVED

Related Links

• A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

MeSH Terms

Conditions

Breast Feeding

Interventions

Lanolin; Milk

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Waxes; Lipids; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Olivera Perić, VII

  Department of Gynecology and Obstetrics, University Clinical Hospital Mostar

  PRINCIPAL INVESTIGATOR

• Anita Pavičić Bošnjak, VII

  Clinical Hospital Centre Zagreb

  STUDY CHAIR

• Vajdana Tomić, VII

  Department of Gynecology and Obstetrics, University Clinical Hospital Mostar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be randomly assigned to two study groups. An envelope containing a note, "mother's milk group" or "lanolin group" will be randomly distributed among women by a midwife who is not a part of the study. The participants will know which group they belong to. A single blind masking will be used during telephone data collection on day three and seven of treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Olivera Perić MSc, Head nurse Department of Gynecology and Obstetrics

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: November 6, 2019
• Study Start: January 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

BO (1)